# K151672: Cerner CareAware Event Management

- Pathway: 510(k) (Traditional)
- Applicant: Cerner Corporation
- Decided: Dec 21, 2015 after 182 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points. Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alarm notification is the device or system producing the alarm or event. This device is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices. CareAware Event Management™ is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does CareAware Event Management™ come into direct contact with patients.

Source page: https://510kreport.com/device/K151672
Methodology: https://510kreport.com/methodology